Harvoni versus Olysio & Sovaldi versus Viekira Pak

A Hep Forum member with genotype 1b hepatitis C was preparing for a doctor’s appointment. The member asked the group for feedback on Harvoni versus Viekira Pak. The member had a low viral load and no cirrhosis. We have stepped in to a new age, one where the choice is a bit more complicated. 

There is now an assortment of hepatitis C treatments. For genotype 1, the choices are Harvoni, Olysio/Sovaldi, and Viekira Pak. In a moment, I will compare these three treatments, but keep in mind that not everyone actually gets to choose, not even your doctor. Insurance companies and specialty pharmacies are removing these choices by negotiating with drug makers for exclusive deals in exchange for lower costs. First, Express Scripts announced it would only offer AbbVie’s Viekira Pak for its genotype 1 patients. The deal included the announcement that Express Scripts would treat all stages of liver disease, and not just those with stages 3 or 4. CVS and Anthem announced that they would carry Sovaldi and Harvoni, although the precise details were not announced. Your medical provider can fight to override this, but the appeal process may be frustrating and time-consuming, and may end up in a denial.  

 

Leaving insurance payers out of it, let’s review the basic hepatitis C treatment guidelines for initial treatment, written by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA). They recommend Harvoni, Olysio/Sovaldi, and Viekira Pak for genotype 1 hepatitis C. Here is a breakdown of the treatment-naive recommendations for genotype 1 patients, along with my annotations.

  Regimen: A daily pill for 12 weeks /8 weeks if viral load is <6 million; no ribavirin 

  Cure Rates: Sustained virologic response rates at 12 weeks (SVR12) were 97 to 99 percent, regardless of cirrhosis (ION Study)

  Side Effects (most common): diarrhea, fatigue, headache, insomnia, nausea 

  Noteworthy Features: No ribavirin; possible short treatment if viral load is <6 million; shortest treatment for those with cirrhosis; one daily pill; minimal side effects; check for potential drug interactions prior to taking

  Regimen: Two daily pills (one Olysio + one Sovaldi) with/without ribavirin (up to 6 pills divided in to 2 daily doses) for 12 weeks (no cirrhosis) or 24 weeks (compensated cirrhosis)

  Cure Rates: SVR12 rates were 95 percent with stage F0 to F3 fibrosis on 12 weeks of treatment; 86 percent for those with cirrhosis; patients with cirrhosis who received 24 weeks of therapy had 100 percent SVR12 rates (COSMOS Study, which was small)

  Side Effects (most common): rash/itching (including a potentially serious photosensitivity reaction), nausea, fatigue, headache, nausea

  Ribavirin side effects: anemia, dizziness/lightheadedness, fatigue, impaired concentration, increased heart rate, insomnia, loss of appetite, mood issues (anxiety, depression, irritability, moodiness), nausea, rash/itching/dry skin, shortness of breath, taste perversion, upset stomach, weakness

  Noteworthy Features: longer treatment for those with cirrhosis; side effects, especially with ribavirin; the role of ribavirin has not been determined; check for potential drug interactions prior to taking   

VIEKIRA PAK + ribavirin

  Regimen: Two ombitasvir, paritaprevir, ritonavir tablets once daily (in the morning) and one dasabuvir 250 mg tablet twice daily (morning and evening) with a meal with ribavirin (up to 6 pills divided in to 2 daily doses) for 12 weeks (no cirrhosis) or 24 weeks (compensated cirrhosis) 

  Cure Rates: 

    No cirrhosis - SVR12 rates were 95 percent for 12 weeks of treatment using ribavirin         (SAPPHIRE-I Study); SVR12 was 97percent for 12 weeks of treatment using ribavirin; 90 percent without ribavirin  (PEARL-IV Study)

   Cirrhosis - SVR12 rates were 89 percent in the 12-week arm and 95percent in the 24-week arm; prior treatment null responders had lower SVR rates (TURQOUISE-II Study)

  Side Effects (most common): nausea, itching, insomnia

  Ribavirin side effects: anemia, dizziness/lightheadedness, fatigue, impaired concentration, increased heart rate, insomnia, loss of appetite, mood issues (anxiety, depression, irritability, moodiness), nausea, rash/itching/dry skin, shortness of breath, taste perversion, upset stomach, weakness

  Noteworthy Features: Uses ribavirin; lots of pills to manage, and higher risk for drug resistance; longer treatment regimen; side effects, especially with ribavirin; more potential drug interactions - check prior to taking   

HARVONI 

  Regimen: A daily pill for 12 weeks /8 weeks if viral load is <6 million; no ribavirin 

  Cure Rates: Sustained virologic response rates at 12 weeks (SVR12) were 97 to 99 percent, regardless of cirrhosis (ION Study)

  Side Effects (most common): diarrhea, fatigue, headache, insomnia, nausea 

  Noteworthy Features: No ribavirin, possible short treatment if viral load is <6 million; shortest treatment for those with cirrhosis, one daily pill; minimal side effects; check for potential drug interactions prior to taking 

  Regimen: Two daily pills (one Olysio + one Sovaldi) with/without ribavirin (up to 6 pills divided in to 2 daily doses) for 12 weeks (no cirrhosis) or 24 weeks (compensated cirrhosis)

  Cure Rates: Date expected mid-2015; preliminary data shows SVR12 rates were 90 to 100 percent (COSMOS Study).

  Side Effects (most common): rash/itching (including a potentially serious photosensitivity reaction), nausea, fatigue, headache, nausea

  Ribavirin side effects: anemia, dizziness/lightheadedness, fatigue, impaired concentration, increased heart rate, insomnia, loss of appetite, mood issues (anxiety, depression, irritability, moodiness), nausea, rash/itching/dry skin, shortness of breath, taste perversion, upset stomach, weakness

  Noteworthy Features: longer treatment for those with cirrhosis; the role of ribavirin has not been determined; high response rate for genotype 1b; side effects, especially with ribavirin; check for potential drug interactions prior to taking  

  Regimen: Two ombitasvir, paritaprevir, ritonavir tablets once daily (in the morning) and one dasabuvir 250 mg tablet twice daily (morning and evening) with a meal for 12 weeks if no cirrhosis; with ribavirin (up to 6 pills divided in to 2 daily doses) with cirrhosis

  Cure Rates: 

    No cirrhosis - SVR12 rates were 99 percent for 12 weeks of treatment using ribavirin (PEARL-III Study)

    Cirrhosis: SVR12 rates were 98.5 percent in the 12-week arm (with ribavirin) and 100 percent in the 24-week arm; prior treatment null responders had lower SVR rates (TURQOUISE-II Study)

  Side Effects (most common): nausea, itching, insomnia

  Ribavirin side effects: anemia, dizziness/lightheadedness, fatigue, impaired concentration, increased heart rate, insomnia, loss of appetite, mood issues (anxiety, depression, irritability, moodiness), nausea, rash/itching/dry skin, shortness of breath, taste perversion, upset stomach, weakness

  Noteworthy Features: High response rate for genotype 1b; no ribavirin in non-cirrhotic patients; lots of pills to manage, and higher risk for drug resistance; longer treatment regimen and ribavirin with cirrhosis; side effects, especially with ribavirin; more potential drug interactions - check prior to taking

What did the Hep Forum member end up with? Harvoni.